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Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain

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ClinicalTrials.gov Identifier: NCT04008043
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Boston University

Brief Summary:

The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study.

Secondary objectives include:

To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.

To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.


Condition or disease Intervention/treatment Phase
Oral Surgery Drug: Vicodin Drug: Dexamethasone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone
Participants in this arm will take a 6mg dexamethasone tablet the day before surgery, a 6 mg tablet the day of surgery, a 4mg tablet the day after surgery and a 2mg tablet the second day after surgery. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Drug: Dexamethasone
In addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Other Name: corticosteroid

Active Comparator: Vicodin
Participants in this arm will take a vicodin tablet every 4-6 hrs as needed to a maximum of 8 tablets after surgery. Each tablet has 300 mg acetaminophen and 5 mg hydrocodone. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Drug: Vicodin
In addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Other Name: acetaminophen and hydrocodone




Primary Outcome Measures :
  1. Study enrollment rate of eligible participants [ Time Frame: 12 months ]
    The proportion of patients that provide consent for the study


Secondary Outcome Measures :
  1. Number of participants with breakthrough pain [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
  2. Post oral surgery pain perception by the patient using NRS [ Time Frame: evening of the surgery, the day after the surgery, one week after the surgery ]
  3. Post oral surgery pain perception by the patient using VSR-4 [ Time Frame: evening of the surgery, the day after the surgery, one week after the surgery ]
  4. Number medications taken for breakthrough pain [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
  5. Medications taken for breakthrough pain [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
  6. Impact of BMI on pain perception [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
    BMI is the weight in kilograms divided by height in meters squared. Body mass index will be categorized as non-obese (BMI < 30kg/m2) or obese (BMI ≥ 30 kg/m2) and pain scores will be stratified and adjusted for the BMI.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be scheduled for periodontal surgery
  • Subjects must be aged 21 years old and above
  • Able and willing to provide informed consent
  • 20 non-obese patients with BMI less than 30kg/m2
  • 20 obese patients with BMI greater than or equal to 30kg/m2
  • Diabetic and hypertensive patients included

Exclusion Criteria:

  • Patients allergic to any formulations used in the study
  • Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month
  • Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history
  • Patients with kidney dysfunction
  • Patients at risk for infective endocarditis determined by the medical history or past medical records

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008043


Contacts
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Contact: Sherif Said, BDS 617-358-8300 sherifyz@bu.edu
Contact: Maha Almohamad, BSA 617-358-8300 malmo@bu.edu

Locations
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United States, Massachusetts
Henry M. Goldman School of Dental Medicine Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Sherif Said, BDS    617-358-8300    sherifyz@bu.edu   
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Sherif Said, BDS BU Goldman School of Dental Medicine

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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04008043     History of Changes
Other Study ID Numbers: H-38061
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston University:
Dexamethasone
Vicodin
Pain management

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Acetaminophen, hydrocodone drug combination
Acetaminophen
Hydrocodone
Oxycodone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents